Ultrasound to Facilitate Stone Passage

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial Description

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia. Subjects will be included across three phases: Phase 1: 20 subjects to demonstrate initial feasibility Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT) Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI) This study is currently in Phase 1. Phase 2a and 2b are intended to be conducted in parallel and will not be initiated until after review of the Phase 1 results and approval to proceed to Phase 2 by the FDA. Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04796792
Study type	Interventional
Source	University of Washington
Contact	Michael Bailey, PhD
Phone	206-619-2035
Email	mbailey@uw.edu
Status	Not yet recruiting
Phase	N/A
Start date	July 1, 2023
Completion date	October 31, 2028

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04924790` - The Effect of the COVID-19 on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions
Recruiting	`NCT05701098` - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)	N/A
Recruiting	`NCT05574517` - Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter	N/A
Withdrawn	`NCT00388271` - Use of Alfuzosin in Stone Treatment With ESWL	Phase 3
Recruiting	`NCT02298465` - ESWL for Distal Ureteric Stone: Supine Versus Prone	N/A
Active, not recruiting	`NCT01973088` - Screening and Identification of Human Urate Transporter hURAT1 MicroRNA	N/A
Recruiting	`NCT01884870` - Silent Ureteral Stone: Impact on Renal Function and Kidney Anatomy	N/A
Active, not recruiting	`NCT00575432` - Evaluation of Kidney Function by Multi-modal Magnetic Resonance Imaging and Spectroscopy
Completed	`NCT05027971` - Flexiva Pulse Registry
Terminated	`NCT00199524` - Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate	Phase 4
Recruiting	`NCT05048706` - SP TLF Versus Ho:YAG Laser	N/A
Not yet recruiting	`NCT04110574` - Computed Tomography Evaluation of Urinary Stones Densities Compared to in Vitro Analysis of Its Chemical Composition
Recruiting	`NCT02594631` - Shock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.	Phase 4
Completed	`NCT00857090` - Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones	Phase 1/Phase 2
Completed	`NCT04112160` - Prospective Randomized Controlled Trial for Pain Relief After Office Ureteral Stent Removal	Phase 2
Completed	`NCT04594161` - Effectiveness of Drainage by PCN vs. JJ in Patients With Symptoms of Obstructive Kidney Disease Caused by Urolithiasis	N/A
Recruiting	`NCT05270421` - Effect of Furosemide on ESWL Outcomes for Renal and Ureteral Calculi	Phase 3
Completed	`NCT02983409` - Analysis the Relationship Between the Abdomen CT and Outcomes in Acute Urinary Stone Patients	N/A
Not yet recruiting	`NCT00397397` - Comparative Treatment Study in Patients With Lower Ureteral Stones	Phase 0
Completed	`NCT00199459` - Proteomic Study of Urinary Stone Disease	N/A